Emperra GmbH has launched a new Bluetooth insulin pen model. The new ESYSTA BT pen is equipped with a Bluetooth interface and transfers the injected insulin doses directly to the patient’s digital blood glucose diary. The smart insulin pens are automatically connected via the 868 MHz interface (similar to the ISM band), which are already being successfully used in medicine in combination with a wireless transmission blood glucose meter as an integrated diabetes management system, ESYSTA.
Both the hardware components and software solutions (ESYSTA portal, ESYSTA app) have been certified as CE-compliant medical products.
“The smart insulin pen and corresponding software appeal to patients and doctors who prefer state-of-the-art technical solutions and who have recognized that the digitalization of diabetes management is a simple and reliable solution,” said Dr. Christian Krey, CEO of Emperra GmbH.
With the help of innovative sophisticated software solutions compliant with medical products and the highest integrated data security standards ISO/IEC 27001, several teams of doctors can even solve complex issues with patients whose levels are hard to adjust telemetrically for the first time worldwide using unadulterated insulin data from insulin pens.
The mobile CE-compliant ESYSTA app for iOS and Android plays the treatment recommendations back, among other things using innovative traffic light algorithms. ESYSTA convinced most patients, their doctors and care-givers within the first few months during a medical and health economic field trial by German health insurance companies. Besides being listed in the reimbursement catalogue of all statutory health insurance companies, digital diabetic services are being contractually agreed as an important business area for Emperra for the first time in Germany.
“We are proud that we can use all U-100 insulins in 3 ml cartridges with the development of specially customized adapters. As a result, every insulin-dependent patient can be equipped with ESYSTA, regardless of whether the insulin comes from Lilly, Sanofi or Novo Nordisk. Even the accidental mixing up of basal and bolus ESYSTA pens and priming (deaeration) can be identified on the ESYSTA portal,” said Dr. Janko Schildt, founder and managing director responsible for medicine and technology.
On the basis of the available scientific data and reimbursement by statutory health insurance companies on the complex German healthcare market, Emperra is striving to use this smart insulin pen based ESYSTA telemonitoring solution with an FDA filing process for the US market. FDA clearance is expected in 2016.